US10188429B2 - Vertebral fixation system - Google Patents

Vertebral fixation system Download PDF

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Publication number
US10188429B2
US10188429B2 US14/794,329 US201514794329A US10188429B2 US 10188429 B2 US10188429 B2 US 10188429B2 US 201514794329 A US201514794329 A US 201514794329A US 10188429 B2 US10188429 B2 US 10188429B2
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Prior art keywords
rod
elongated member
member
configured
system
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US14/794,329
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US20150305780A1 (en
Inventor
Daniel Carlson
Hugh Hestad
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Zimmer Spine Inc
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Zimmer Spine Inc
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Priority to US13/687,220 priority Critical patent/US20140148854A1/en
Application filed by Zimmer Spine Inc filed Critical Zimmer Spine Inc
Priority to US14/794,329 priority patent/US10188429B2/en
Publication of US20150305780A1 publication Critical patent/US20150305780A1/en
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Publication of US10188429B2 publication Critical patent/US10188429B2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7019Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7026Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
    • A61B17/7029Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form the entire longitudinal element being flexible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7049Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7053Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage

Abstract

A vertebral fixing system having a flexible elongated member, a connecting part, and an anchor, where the anchor may engage a bone structure (e.g., a vertebra) through an opening of the connecting part and the flexible elongated member may connect to the connecting part. In some cases, the vertebral fixing system may include a tightening part configured to apply a tension to the elongated member and/or secure the elongated member with respect to the connecting part. The vertebral fixing system may be configured to receive a rod and may be capable of connecting thereto. The connecting part may have a plurality of connecting members, where at least one of the connecting members includes an opening for receiving the anchor and at least one of the connecting members connects to the elongated member.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 13/687,220, filed on Nov. 28, 2012, the contents of which are fully incorporated herein by reference.

TECHNICAL FIELD

The disclosure is directed to vertebral fixing systems. More particularly, the disclosure is directed to vertebral fixing systems suitable for being mounted on a vertebra.

BACKGROUND

The spine is constituted by superposed vertebrae that are normally in alignment along a vertical axis going from the lumbar vertebrae to the cervical vertebrae, each vertebrae presenting a posterior wall from which there projects a spinous process and two sides having walls from which there project the ribs and/or transverse processes. When the spine of an individual presents abnormal curvature, the vertebrae are inclined relative to one another and/or relative to the vertebral axis. For example, the sides of the vertebrae situated on one side may be moved closer together forming a concave side, whereas the sides of the vertebrae on the other side may be spaced apart from one another and form a convex side.

In order to straighten the spinal column, a spinal stabilization system may be surgically installed along a vertebral segment. In order to keep the vertebrae in a desired relative position, known devices have screws that are inserted in the vertebrae and/or hooks that are inserted along the inside wall of the vertebral canal, and rods that are for interconnecting the screws and/or the hooks.

SUMMARY

The disclosure is directed to several alternative or complementary designs, materials, and methods of using medical device structures and assemblies. Although it is noted that conventional vertebral fixing systems and similar devices exist, there exists a need for improvement on those devices.

Accordingly, one illustrative embodiment of the disclosure may include a vertebral fixing system having an elongated member (e.g., a flexible elongated member), a connecting part, and an anchor, where the anchor may engage a bone structure through an opening in the connecting part and the elongated member may connect to the connecting part. The elongated member may be flexible and may connect to the connecting part in any manner. For example, the elongated member may be looped through an opening in the connecting part (e.g., the opening through which the anchor may be inserted and/or through a different opening), the elongated member may be mechanically fixed to the connecting part through gluing, applying pressure, clamping, riveting, sewing, or other mechanical fixation or fastening techniques, and/or the elongated member may be connected to the connecting part in any other manner, as desired.

In some cases, the connecting part may have a first connecting member with an opening and a second connecting member with an opening, where the bone anchor may be inserted through the opening of the first connecting member and/or the opening of the second connecting member to engage a bone structure. Illustratively, the first connecting member and the second connecting member may be movable with respect to the other of the first connecting member and the second connecting member. Alternatively, the first connecting member and the second connecting member may be unitarily formed and substantially fixed with respect to the other of the first connecting member and the second connecting member. Each, or at least one, of the connecting members may be connected to the elongated member(s).

In some illustrative instances, the vertebral fixing system may include a tightening part. The tightening part may be in adjustable connection with the elongated member and may be configured to secure the elongated member with respect to the connecting part. In an illustrative example, the elongated member connected to the connecting part may be wrapped around a bone structure or other structure and inserted into the tightening part, where the tightening part may be used to retain and/or apply a tension in and/or to the inserted elongated member and/or secure the elongated member in a position with respect to the connecting part.

In some instances, the vertebral fixing system may be used in a method of manipulating spinal anatomy. For example, the anchor of the vertebral fixing system may be inserted through an opening of the connecting part and connected to a first portion of the spinal anatomy. In the example, the elongated member connected to the connecting part may be extended around a second portion of the spinal anatomy and inserted into a tightening member or part. Then, the elongated member extending between the connecting part and the second portion of the spinal anatomy may be tensioned and locked into a position with the tightening member to maintain a tension in the elongated member.

The above summary of some example aspects is not intended to describe each disclosed embodiment or every implementation of the claimed disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:

FIG. 1 is a schematic perspective view of an illustrative vertebral fixing system according to an aspect of the disclosure;

FIG. 2 is a schematic perspective view of an illustrative vertebral fixing system according to an aspect of the disclosure;

FIG. 3A is a schematic perspective view of an illustrative vertebral fixing system according to an aspect of the disclosure;

FIG. 3B is a schematic perspective partially exploded view of an illustrative vertebral fixing system according to an aspect of the disclosure;

FIG. 4 is a schematic sectional view of a feature of an illustrative vertebral fixing system according to an aspect of the disclosure, where the illustrative vertebral fixing system is engaging a bone structure;

FIG. 5A is a schematic sectional view of an illustrative vertebral fixing system according to an aspect of the disclosure, where the illustrative vertebral fixing system is in an unlocked position;

FIG. 5B is a schematic sectional view of the illustrative vertebral fixing system depicted in FIG. 5A, where the illustrative vertebral fixing system is in a preliminary locking position;

FIG. 5C is a schematic sectional view of the illustrative vertebral fixing system depicted in FIG. 5A, where the illustrative vertebral fixing system is in a final locking position;

FIG. 6 is a schematic plan view of an illustrative vertebral fixing system according to an aspect of the disclosure, where the illustrative vertebral fixing system is engaging a bone structure;

FIG. 7 is a schematic sectional view of the illustrative vertebral fixing system of FIG. 6;

FIG. 8 is a schematic perspective view of an illustrative vertebral fixing system including a spacer according to an aspect of the disclosure;

FIG. 9 is a schematic sectional view of an illustrative vertebral fixing system including a spacer according to an aspect of the disclosure, where the illustrative vertebral fixing system is engaging a bone structure;

FIG. 10 is a schematic sectional view of an illustrative vertebral fixing system including a spacer according to an aspect of the disclosure, where the illustrative vertebral fixing system is engaging a bone structure;

FIG. 11 is a schematic sectional view of an illustrative vertebral fixing system including a spacer according to an aspect of the disclosure, where the illustrative vertebral fixing system is engaging a bone structure;

FIG. 12A is a schematic perspective view of an illustrative vertebral fixing system including an elongated member and a spacer according to an aspect of the disclosure;

FIG. 12B is an expanded schematic side view taken of the illustrative vertebral fixing system including a spacer depicted in FIG. 12A, where the dotted lines show features interior of the spacer;

FIG. 13 is a schematic side view of an illustrative vertebral fixing system including an elongated member and a spacer according to an aspect of the disclosure;

FIG. 14 is a schematic perspective view of an illustrative vertebral fixing system according to an aspect of the disclosure;

FIG. 15 is a schematic perspective view of illustrative interior features of the illustrative vertebral fixing system depicted in FIG. 14, where a housing of the illustrative vertebral fixing system is depicted as being transparent; and

FIG. 16 is a schematic flow diagram of an illustrative method for manipulating spinal anatomy using an illustrative vertebral fixing system according to an aspect of the disclosure.

While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the claimed disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claimed disclosure.

DESCRIPTION

For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may be indicative as including numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges and/or values pertaining to various components, features and/or specifications are disclosed, one of skill in the art, incited by the present disclosure, would understand desired dimensions, ranges and/or values may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

As used herein, the proximal end (i.e., trailing end) of an object is the end that is closest to the individual or instrument inserting the object during a medical procedure and the distal end (i.e., leading end) of an object is the end that is farthest from the individual or instrument inserting the object during a medical procedure.

As used herein, any numerical or other order designations of elements (e.g., first, second, third, a, b, c, etc.) are used for descriptive purposes to improve the clarity of the description of the disclosure and differentiate between similar disclosed features. These numerical indications, unless expressly indicated, are not used for any limiting purposes.

The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the claimed disclosure. The illustrative embodiments depicted are intended only as exemplary. Selected features of any illustrative embodiment may be incorporated into an additional embodiment unless clearly stated to the contrary.

Turning to the figures, FIGS. 1-15 depict illustrative vertebral fixing systems 10. Generally, vertebral fixing systems 10 may include an elongated member 12 (e.g., a flexible elongated member or ligature, as shown in FIGS. 1-15, or an inflexible elongated member), a connecting part 14, an anchor 16 (e.g., a bone anchor, a bone screw, or other fastener or anchor), and/or a tightening part 18. In some instances, illustrative vertebral fixing systems 10 may be configured to engage a bone (e.g., a vertebra, a rib, or other bone structure) via the bone anchor 16, the elongated member 12, and/or any other feature, where the elongated member 12 may extend from the connecting part 14 and may be configured to be wrapped around at least a portion of a bone structure and inserted into the tightening part 18.

In some illustrative cases, the connecting part 14 may be configured in the shape of a grommet or washer and may include an opening(s) 20 through which objects may be received or inserted (e.g., a first opening 20 a and a second opening 20 b, as shown in FIG. 1, or any other number of openings 20). For example, in some instances the connecting part 14 may be a flat member having an upper surface, a lower surface opposite the upper surface, and one or more, or a plurality of openings 20 extending through the connecting part 14 from the upper surface to the lower surface. The lower surface of the connecting part 14 may be configured to face and/or contact a bony structure of a vertebra. The connecting part 14 may devoid of any structure (e.g., an elongate channel) for coupling the connecting part 14 to a spinal rod and thus not be configured to be coupled to an elongate spinal rod.

Illustratively, the opening(s) 20 may be sized and/or otherwise configured to receive the threaded anchor 16 and/or the elongated member 12. For example, the opening 20 may be sized such that the threaded anchor 16 may be inserted through the opening 20 to engage a vertebra and to position the connecting part 14 with respect to the vertebra (e.g., with the lower surface bearing against a bony structure of the vertebra). In some instances, the anchor 16 may be removable from the connecting part 14, or the anchor 16 may be configured to be retained with the connecting part 14. For example, in some instances the anchor 16 may be pre-assembled with the connecting part 14 during manufacture, and provided as an assembly during a surgical procedure. In some such instances, the anchor 16 may be rotatable relative to the connecting part 14 but not removable from the connecting part 14. In the example, once the anchor 16 is inserted through the opening 20 and engaging the vertebra, connecting part 14 may be in a fixed position relative to the vertebra or the connecting part 14 may be in an adjustable position with respect to the vertebra.

The connecting part 14 may be made of any material. For example, the connecting part 14 may be made of a metal material, a polymer material, or any other similar or dissimilar material, as desired. The opening(s) 20 in the material of the connecting part 14 may be formed through any technique. For example, the opening(s) 20 may be punched out, drilled out, or milled out of the material of the connecting part 14, molded into the material of the connecting part 14, and/or developed in any other similar or dissimilar manner.

In some instances, the elongated member 12 (e.g., a flexible elongated member) may have a first portion 12 a, a second portion 12 b, and a third portion 12 c (e.g., an intermediate portion) extending between the first portion 12 a of the elongated member 12 and the second portion 12 b of the elongated member 12, where the first portion 12 a and the second portion 12 b of the elongated member 12 may be end portions. Illustratively, the first portion 12 a, the second portion 12 b, and/or the third portion 12 c of the elongated member 12 may be configured to engage the connecting part 14 in any manner. For example, the elongated member 12 may mechanically engage the connecting part(s) 14 (see FIGS. 2 and 3), the elongated member 12 may be threaded through the opening 20 (e.g., the second opening 20 b, as shown in FIG. 1) of the connecting part 14, or the elongated member 12 may engage the connecting part in any other manner, as desired. In some instances, the second portion 12 b may be attached (e.g., stitched, glued, riveted, etc.) to the first portion 12 a, forming a loop portion with the third portion 12 c extending through the opening 20 b, with only the first portion 12 a being a free end portion extending from the connecting part 14. In other instances, the first portion 12 a and the second portion 12 b may both be free end portions extending from the connecting part 14. Example mechanical engagements between the connecting part 14 and the elongated member 12 include, but are not limited to, welded engagements, glued engagements, press-fit or crimped engagements, clamped engagements, riveted engagements, etc.

As discussed, the connecting part 14 may include the first opening 20 a and the second opening 20 b. In such instances, the anchor 16, illustratively, may be configured to be inserted through the first opening 20 a to engage a portion of an anatomy (e.g., a bone) accessible through the first opening 20 a. The second opening 20 b may facilitate the connection between the connecting part 14 and the elongated member 12, as shown in FIG. 1. For example, the elongated member 12 may connect to the connecting part 14 via insertion through the second opening 20 b of the connecting part 14 and wrapping the elongated member around the connecting part 14. The second opening 20 b may be arranged laterally from the first opening 20 a, such that the second opening 20 b is located within a portion of the connecting part 14 extending away from the anchor 16.

In some instances, the connecting part 14 may include a first connecting member 14 a and a second connecting member 14 b having an opening 20, as shown in FIGS. 3A and 3B. When engaged by an anchor 16 and/or when separate from the anchor 16, the first connecting member 14 a and the second connecting member 14 b of the connecting part 14 may be fixed relative to one another (e.g., unitarily formed, as shown in FIG. 3A, or fixed relative to one another in any other manner). Alternatively, as shown in FIG. 3B, the first connecting member 14 a of the connecting part 14 and/or the second connecting member 14 b of the connecting part 14 may be configured to be adjusted relative to one another (e.g., pivoted about an anchor 16 received through the opening 20 of the first connecting member 14 a and/or the opening of the second connecting member 14 b, and/or otherwise movable with respect to the other connecting member 14 a, 14 b).

As illustrated in FIG. 3A, the first connecting member 14 a and the second connecting member 14 b may be unitarily configured and have a single opening 20 configured to receive the anchor 16. Alternatively, as shown in FIG. 3B, each of the first connecting member 14 a and the second connecting member 14 b may be separately configured and may have separate openings 20 configured to receive the anchor 16. The openings 20 of the first connecting member 14 a and the second connecting member 14 b may be positioned and/or aligned with respect to one another such that the anchor 16 may be inserted through the opening 20 of the first connecting member 14 a and the opening 20 of the second connecting member 14 b to engage a bone (e.g., a vertebra, a rid, or other bone structure).

The elongated member 12 may engage the first connecting member 14 a and/or the second connecting member 14 b in any manner. In some instances, an elongated member 12 may extend from each of the first connecting member 14 a and the second connecting member 14 b. For example, each of the first connecting member 14 a and the second connecting member 14 b may include a first opening 20 a and a second opening 20 b, where an elongated member 12 may be threaded through each of the second openings 20 b of the respective first connecting member 14 a and the second connecting member 14 b or a single elongated member 12 may be threaded through both of the second openings 20 b of the respective first connecting member 14 a and the second connecting member 14 b. Alternatively, an elongated member 12 may mechanically engage each of the first connecting member 14 a and the second connecting member 14 b or a single elongated member 12 may mechanically engage both of the second openings 20 b of the respective first connecting member 14 a and the second connecting member 14 b.

The tightening part 18 or clamping part may be any configuration capable of engaging the first portion 12 a of the elongated member 12, the second portion 12 b of the elongated member 12, and/or the third portion 12 c of the elongated member 12 to secure the elongated member 12 with respect to the connecting part 14, the anchor 16, and/or any other feature, as desired. For example, the tightening part 18 may have a configuration that includes a one-way catch mechanism 22 (e.g., a gear, zip-tie head), a release 24 to allow for adjustment of the elongated member 12 with respect to a bone (e.g., a vertebra) or other piece of human anatomy, and/or any other engaging and/or tightening features, as desired. Alternatively, or in addition, in some instances, the tightening part 18 may be configured to receive and engage a portion of the elongated member 12 (e.g., the second portion 12 b of the elongated member 12) that has been wrapped and/or extended around a bone (e.g., a vertebra, a rib, or other bone) to substantially secure the portion of the elongated member 12 with respect to the connecting part 14, the anchor 16, the bone, and/or the other feature.

The tightening part 18 may be made of any material. For example, the tightening part 18 may be made of a metal material, a polymer material, or any other similar or dissimilar material, as desired.

Illustratively, the tightening part 18 may be configured to be in adjustable connection with the flexible elongated member 12. In some cases, the tightening part 18 may include a one-way catch mechanism 22. For example, the one-way catch mechanism may include a pivoted cam-shaped pawl, (as shown in FIG. 4), a zip-tie head, ratcheting teeth, or other fastener features. The one-way catch mechanism 22 may be configured to allow the elongated member 12 to be inserted in a first direction by pulling or moving the elongated member 12 through the tightening part 18 in the first direction. Once the elongated member 12 is inserted, the one-way catch mechanism 22 may be configured to prevent movement of the elongated member 12 through the tightening part 18 in a second direction, substantially opposite the first direction.

In some cases, a cam-shaped pawl portion 40 of the tightening part 18 may include a toothed catch mechanism 42, as shown in FIG. 4, where the catch mechanism 42 may engage the elongated member 12 against a surface of the tightening part 18 to maintain the elongated member 12 in a position with respect to the tightening part 18. The catch mechanism 42 may be spring loaded and/or otherwise biased toward the second direction and may pivot about a pivot feature 46 (e.g., a pin, a screw, a nail, etc.) of the catch mechanism 42. In operation, when the elongated member 12 is moved in the first direction through the cam-shaped pawl 40 of the tightening part 18 or a force in substantially the first direction is applied to the elongated member 12 inserted into the cam-shaped pawl 40 and/or when the release 24 (e.g., a pawl) is pressed against catch mechanism 42, the catch mechanism 42 may pivot about the first pivot feature 46 to allow the elongated member 12 to advance in substantially the first direction. When the elongated member 12 has ceased movement in the first direction and/or the force in substantially the first direction has been removed from the elongated member 12, the catch mechanism 42 may pivot to a resting position such that the catch mechanism 42 engages the elongated member 12 and the side of the tightening part 18 to substantially prevent movement of the elongated member 12 in substantially the second direction.

Alternatively, or in addition to including a one-way catch mechanism 22, the tightening part 18 or clamping part may have a pivot design, as shown in FIGS. 5A-5C. Illustratively, the tightening part 18 may include a first longitudinal element 50 and a second longitudinal element 52 in a spaced apart position, as shown in FIG. 5A, and configured to pivot about the same axis or different axes. The first longitudinal element 50 and/or the second longitudinal element 52 may be configured to include lock recesses 70. In addition, the first longitudinal element 50 and/or the second longitudinal element 52 may be configured to include a lock tooth or lock teeth 72. The lock teeth 72 on the first longitudinal element 50 and/or the second longitudinal element 52 may be configured to engage the lock recesses(s) 70 of the second longitudinal element 52 and/or the first longitudinal element 50, respectively. For example, as shown in FIGS. 5A-5C, the first longitudinal element 50 may include a first lock recess 70 a and a second lock recess 70 b and the second longitudinal element 52 may include a lock tooth 72, where the lock tooth 72 may engage the first lock recess 70 a when the tightening part 18 is in a preliminary or provisional locking position, as shown in FIG. 5B, and the lock tooth 72 may engage the second lock recess 70 b when the tightening part 18 is in a final locking position, as shown in FIG. 5C.

In some cases, the tightening part 18 may take on other configurations and features and/or be combined with other features. Illustrative tightening parts are disclosed in U.S. Pat. Nos. 8,172,843, 7,959,654, and 7,481,828, which are all expressly herein incorporated by reference in their entireties.

In some instances where the tightening part 18 includes a pivot design, the flexible elongated member 12 may be received or engaged in a first opening 54 in the first longitudinal element 50 and a second opening 56 in the second longitudinal element 52 against a portion of a first inside wall 58 of a first recess 62 of the first longitudinal element 50 and/or a second inside wall 60 of a second recess 64 of the second longitudinal element 52. In some cases, a rod 66 may be introduced into the first recess 62 of the first longitudinal element 50 and/or the second recess 64 of the second longitudinal element 52 such that the elongated member 12 may be disposed between the first inside wall 58 and the second inside wall 60 of the first recess 62 and the second recess 64, respectively, and the rod 66.

As shown in FIGS. 5A-5C, the third portion 12 c of the elongated member 12 may define a loop 68 that may extend beyond an outer surface of the first longitudinal element 50 or second longitudinal element 52 from the first opening 54. In addition, the first portion 12 a of the elongated member 12 and the second portion 12 b of the elongated member 12 may extend beyond an outer surface of the second longitudinal element 52 or the first longitudinal element 50 from the second opening 56. When the first longitudinal element 50 and the second longitudinal element 52 are spaced in the provisional locking position, as shown in FIG. 5B, the elongated member 12 may be adjusted for final positioning (e.g., the elongated member 12 may be adjusted and/or tightened for final positioning with the one-way catch mechanism of tightening part 18 described herein, with the first longitudinal element 50, the second longitudinal element 52 and the rod 66, and/or with any other similar or dissimilar tightening mechanism). Provisional positioning of the elongated member 12 may allow for frictional movement of the elongated member within the tightening part 18, for example, to adjust tension in the elongated member 12. Once the third portion 12 c of the elongated member 12 forming the loop 68 has been placed around a bone (e.g., a vertebra, rib, or other bone structure 19) or other object and the elongated member is in its final position, a user (e.g., a surgeon) may further engage the second longitudinal element 52 with the first longitudinal element 50 to place the tightening part 18 in the final locking position. Final locking of the elongated member 12 within the tightening part 18 may fix the elongated member 12 in relation to the tightening part 18 or clamping member preventing further movement of the elongate member 12 through the tightening part 18. This multi-step locking system of the tightening part 18 may allow the user to extract traction on the elongated member 12 around the bone or other object and once the tension in the elongated member 12 is sufficient for providing appropriate fastening, the user may finish the tightening process by applying a force to the second longitudinal element 52 to move the second longitudinal element 52 to the final locking position with respect to the first longitudinal element 50.

In some instances, the tightening part 18 may be configured to receive and/or engage a plurality of elongated members 12. For example, as shown in FIGS. 6 and 7, the tightening part 18 may be configured to receive and/or engage two elongated members 12. Illustratively, the tightening part 18 receiving a plurality of elongated members 12 may be configured to tighten each elongated member 12 separately from the others or tighten each elongated member 12 at the same time, where the tightening of the elongated members 12 may be performed with a one-way catch mechanism 22, a set screw 74 and a pressure fit, and/or with any other similar or dissimilar device. Further, the tightening part 18 receiving the plurality of elongated members 12 may be configured to lock each of the plurality of elongated members 12 independently of one another or substantially simultaneously, where the elongated members 12 may be locked in place using teeth and teeth recesses to provisionally lock and finally lock the elongated members 12 in place, using a tightening set screw 74 for each elongated member 12, as shown in FIGS. 6 and 7, a single tightening set screw 74 for the elongated members 12, and/or any other locking or tightening features, as desired.

In some instances, the tightening part 18 may be configured to allow for post-operative and/or percutaneous adjustability of tension in the elongated member 12 received and/or engaged by the tightening part 18 and/or of the positioning of the tightening part 18 with respect to the rod 66. Illustratively, such a tightening part 18, as shown in FIGS. 14 and 15, may include a housing 80, a worm drive 82 having a screw 84 and a worm gear 86, a rod locking screw 88, and/or other features, as desired. As shown in FIG. 14, the housing 80 may have an opening 90, where the worm gear 86 of the worm drive 82 may extend substantially across the opening 90. The opening 90 may be any shape and/or size configured to receive the elongated member 12. In some instances, the housing 80 may include a cover at least partially enclosing the opening 90, where the cover may have a slit(s) or slot(s) for receiving the elongated member 12. Further, the screw 84 of the worm drive 82 and the rod locking screw 88 may be configured to extend from the same side of the housing 80, such that a user (e.g., a surgeon) may access the screw 84 of the worm drive 82 and the rod locking screw 88 at a substantially same angle or access point with respect to the housing 80.

The worm gear 86 may have a geared portion 86 a and a receiving portion 86 b, where the geared portion 86 a may be configured to engage the screw 84 and the receiving portion 86 b may be configured to receive the elongated member(s) 12. The receiving portion 86 b may include a slot 92 through which the elongated member(s) 12 may be received, engaged, and/or wrapped. In some cases, the slot 92 of the receiving portion 86 b of the worm gear 86 may clamp the received elongated member(s) 12 and/or the receiving portion 86 b of the worm gear 86 may otherwise engage the elongated member(s) 12 to facilitate adjusting a tension in the elongated member 12 when the worm gear 86 is rotated. Alternatively, or in addition, the elongated member 12 may be mechanically attached to the receiving portion 86 b of the worm gear 86 and/or the elongated member 12 may be wrapped around worm drive 82.

In operation, once the elongated member(s) 12 have been received by the receiving portion 86 b of the worm gear 86, the screw 84 of the worm drive 82 may be adjusted to adjust a tension in the received elongated member(s) 12. To adjust the tension in the received elongated member(s) 12, the screw 84 of the worm drive 82 may be rotated, such as with an elongated driver, which causes the worm gear 86 to rotate and adjust the tension in the received elongated member(s) 12.

The housing of the tightening part 18 may include an opening (e.g., a hook, U-shaped channel, through hole, or other opening) 94 configured to engage and/or receive the rod 66, as shown in FIGS. 15 and 16. To facilitate securing the housing 80 to the rod 66, the rod locking screw 88 may be adjusted (e.g., rotated) such that it engages the rod 66 received in the opening 94. The tightening of the rod locking screw 88 may apply a force to the rod 66 to secure the housing 80 at a position with respect to the rod 66. Alternatively, or in addition, the rod locking screw 88 may be configured to facilitate securing the housing 80 at a position with respect to the rod 66 through any connection technique including, but not limited to, engaging an opening in the rod 66, and/or any other similar or dissimilar connection technique, as desired.

In such an embodiment, during a medical procedure the tightening part 18 may be inserted through an incision of the patient and be secured to a rod 66 or other construct installed on the vertebrae. Then the elongated member 12 may be tightened to a desired amount by rotating the worm gear 86 via the worm drive 82 with a driver instrument during the medical procedure. Thereafter, the incision may be closed at the conclusion of the medical procedure. In a subsequent revision medical procedure, a small access incision may be made in the patient to gain access to the previously installed tightening part 18, and a driver instrument may be minimally invasively or percutaneously inserted through the small access incision to further adjust the tension of the elongate member 12. For example, the driver instrument may be used to rotate the worm gear 86 via the worm drive 82 in order to adjust the amount of tension applied to the elongate member 12 (e.g., apply less tension or apply more tension). The access incision need only be large enough to advance the elongate shaft of the driver instrument to the driver interface of the worm drive 82, and thus the access incision may not be large enough to pass the tightening part 18 therethrough.

In some instances, the vertebral fixing system 10 may include a spacer 26 (e.g., a bumper). The spacer 26 may be made of any material. For example, the spacer 26 may be made of a metal material, a polymer material, or any other similar or dissimilar material, as desired. In some cases, the spacer 26 may be rigid or inflexible, while in other instances the spacer 26 may be flexible or elastically yielding.

An illustrative spacer 26 may have a first opening 28 a at or near a first end of the spacer 26, a second opening 28 b at or near a second end of the spacer 26, and an extending portion 30 extending between the first end at or near the first opening 28 a of the spacer 26 and the second end at or near the second opening 28 b of the spacer 26. Illustratively, the spacer 26 may be configured to extend between the bone structure 19 and a tightening part 18 (as shown in FIG. 8, where loop 68 may be configured to be wrapped around a bone structure 19), two bone structures 19 (as shown in FIGS. 9 and 10), and/or between other similar or dissimilar features, as desired.

In some cases, the extending portion 30 of the spacer 26 may at least partially define a lumen 32, as shown in FIG. 9. Alternatively, or in addition, the extending portion 30 may be substantially flat or collapsible such that the elongated member 12 may pass through the first opening 28 a of the spacer 26, travel along the extending portion 30, and pass through the second opening 28 b of the spacer 26, as shown in FIG. 13.

The spacer 26 may have a length L extending substantially from the first end of the spacer 26 to the second end of the spacer 26 and the lumen 32 may have a length L′ substantially equal to the length L of the spacer 26, as shown in FIG. 9, or any other length dimension, as desired. Illustratively, the spacer 26 may receive the elongated member 12 in the first opening 28 a of the spacer 26 and/or in the second opening 28 b of the spacer 26, wherein the received elongated member 12 may extend along the spacer 26 and/or at least partially extend through the lumen 32. In use, the spacer 26 may be held in compression while the elongated member 12 may be held in tension.

As shown in FIG. 10, the spacer 26, in some cases, may include a third opening 28 c (e.g., an intermediate opening of the spacer 26). The third opening 28 c may be positioned, for example, at a location between the first opening 28 a of the spacer 26 and the second opening 28 b of the spacer 26. Alternatively, or in addition, the third opening 28 c may be an intermediate opening positioned between a first end 26 a and a second end 26 b of the spacer 26. In some illustrative cases, where the spacer 26 may include the lumen 32, the third opening 28 c may communicate with the lumen 32.

Illustratively, the spacer 26 may receive the elongated member 12 through the first opening 28 a of the spacer 26 and/or the second opening 28 b of the spacer 26, where the elongated member 12 may extend along at least a portion of the spacer 26. For example, the elongated member 12 (e.g., a first portion 12 a, or other portion, of the elongated member 12) may extend into the first opening 28 a of the spacer 26 and/or the elongated member 12 (e.g., a second portion 12 b, or other portion, of the elongated member 12) may extend into the second opening 28 b of the spacer 26 and at least a part of the elongated member 12 (e.g., the first portion 12 a, the second portion 12 b, and/or the third portion 12 c, or other portion of the elongated member 12) inserted into and/or through the first opening 28 a of the spacer 26 and/or the second opening 28 b of the spacer 26 may extend through the third opening 28 c of the spacer 26, as shown in FIG. 10. In the example, the portion(s) of the elongated member 12 inserted into and/or through the third opening 28 c may be received and/or engaged by the tightening part 18. In some instances, the tightening part 18 may engage the elongated member 12 at a position adjacent the third opening 28 c.

In FIG. 11, an illustrative vertebral fixing system 10 is depicted that may include two elongated members 12, a tightening part 18, and two spacers 26 (e.g., a first spacer 27 and a second spacer 29). In some instances, a first elongated member 12 may be wrapped around a bone structure 19, inserted through the first spacer 27, and inserted into the tightening part 18 to apply and/or maintain a tension in the first elongated member 12 and maintain the first spacer 27 in a position with respect to the bone structure 19. Similarly, a second elongated member 12 may be wrapped around a bone structure 19, inserted through the second spacer 29, and inserted into the tightening part 18 to apply and/or maintain a tension in the second elongated member 12 and maintain the second spacer 29 in a position with respect to the bone structure 19. In some cases, the tightening part 18 may abut the first spacer 27 and/or the second spacer 29, as shown in FIG. 11. Alternatively, or in addition, the tightening part 18 may receive and/or engage the first spacer 27 and/or the second spacer 29.

As an alternative to the tightening part 18 having separate pathways for each elongated member 12, as shown in FIG. 11, the tightening part 18 may have a single pathway or interconnected pathways configured to receive a single elongated member or multiple elongated members. For example, a single elongated member 12 may be used with two spacers and one tightening member, where the single elongated member 12 may be wrapped around two bone structures 19, rods 66, other structures, or combinations thereof, and passed through a single pathway or interconnected pathways of the tightening part 18 (e.g., two discrete juxtaposed portions of 12 may pass through a single pathway of the tightening part 18).

As shown in FIGS. 10 and 11, set screws 74 of tightening part 18 may engage the elongated members 12. The set screws 74 may be configured to engage and tighten the elongated member(s) 12 inserted through the spacer 26 and/or tightening part 18. For example, the set screw(s) 74 may be configured to engage the elongated member(s) 12 and tighten the elongated member(s) 12 in a manner that holds the elongated member(s) 12 in a position relative to the tightening part 18.

In some illustrative instances, set screw(s) 34 may engage the spacer 26 (e.g., a bumper and/or a cross-link connector), as shown in FIGS. 12A and 12B. The set screw(s) 34 may be configured to engage any portion of the spacer 26 (e.g., at or near the first end 26 a of the spacer 26, the second end 26 b of the spacer 26, and/or another portion of the spacer 26). The set screw(s) 34 may be configured to extend through a set screw opening 36 extending partially through the spacer 26 or all of the way through the spacer 26. The set screw(s) 34 may engage a hole or opening in the elongated member 12 (e.g., through which a portion of the elongated member 12 may extend) and/or may trap the elongated member 12 between the set screw(s) 34 and a surface the spacer 26, such that the set screw 34 may act on the elongated member 12 to maintain the engaged portion of the elongated member 12 in a desired position relative to the set screw 34.

In some cases, the set screw 34 may engage a portion of the elongated member 12 within the lumen 32 of the spacer and/or may engage a portion of the elongated member 12 extending exterior the spacer 26. For example, the elongated member 12 may be extended through the lumen 32 of the spacer 26, around a bone or rod, optionally through another spacer 26, and back to the spacer 26 with the set screw(s) 34, where the set screw 34 may engage the extended and wrapped elongated member 12 to secure the spacer 26 adjacent or to the bone or rod, as desired. The spacer 26 including the set screw(s) 34 may be used for other purposes and with other techniques where the set screw(s) 34 may be configured to engage the elongated member 12. In some cases, the spacer 26 with the set screw(s) 34 may be utilized as an intermediate component between the elongated member 12 and the bone structure 19.

As shown in FIGS. 12A and 12B, the spacer 26 and the elongated member 12 may be a cross-link connector 31 or transverse connector extending between two rods 66. Alternatively or in addition, the cross-link connector 31 may extend between rods 66, bone structures, anchors, and/or a combination thereof. Illustratively, one of the rods 66 may be configured to extend along a spinal column on a first side of the spinal process and a second rod 66 may be configured to extend along the spinal column on a second side of the spinal process, where the rods 66 may be secured with respect to the spinal column via anchors 16 (e.g., mono-axial pedicle screws, poly-axial pedicle screws, bone anchors, or other securing mechanisms). In some instances, the rods 66 may be located a distance apart and the cross-link connector 31 may be configured to extend substantially the distance between the two rods 66 and receive the elongated member 12. For example, the elongated member 12 may be configured to be wrapped around one of the rods 66 or otherwise secured to the rod 66, extended through at least a portion of the cross-link connector 31, wrapped around another of the rods 66 or otherwise secured to the another of the rods 66, and tightened and/or secured with respect to the cross-link connector 31 through tightening of the set screw(s) 34. Such an arrangement of the cross-link connector 31 may add stability to the positioning of the rods 66 with respect to one another and/or have other benefits.

Illustratively, the vertebral fixing system 10 may used in a method 100 for manipulating spinal anatomy. For example, the anchor 16 may be inserted through an opening 20 of the connecting part 14 (step 110), such that the elongated member 12 may be connected to the connecting part 14. In some cases, the anchor 16 may engage or connect to the connecting part 14 in any other manner, as desired. After or before (or while) the elongated member 12 is (being) inserted through the opening 20 of the connecting part 14, the anchor 16 may be connected (e.g., through a screwing technique or other connecting technique facilitated by the design and/or structure of the anchor 16) to a first object (e.g., first portion of the spinal anatomy, a rod 66, etc.) (step 112) to secure the connecting part 14 relative to the first object. The elongated member 12 connected to the connecting part 14 may be extended around (or otherwise put in communication with) a second object (e.g., a second portion of the spinal anatomy, a rod 66, etc.) (step 114). Further, a first portion 12 a and/or a second portion 12 b of the elongated member 12 may be inserted into or otherwise engage a tightening part 18 (step 116). For example, once the elongated member 12 has been extended around the second object, the first portion 12 a and/or the second portion 12 b of the elongated member 12 may be inserted into the tightening part 18. A user may tension a portion of the elongated member 12 extending between the connecting part 14 and the second object with the tightening part 18 or any other feature (step 118). The tension may be applied in any manner. For example, the tensioning (step 118) may be applied by pulling the elongated member 12 around the spinal anatomy and through the tightening member 18 with a tensioning device and/or in any other manner, as desired. Once a desired tension has been applied to the elongated member 12, the elongated member 12 inserted into the tightening part 18 may be locked or fixed (step 120) within the tightening part 18 to maintain a tension in the tensioned portion of the elongated member 12.

Those skilled in the art will recognize that the present disclosure may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departure in form and detail may be made without departing from the scope and spirit of the present disclosure as described in the appended claims.

Claims (21)

What is claimed is:
1. A system for post-operative adjustment of a spinal stabilization system, comprising:
a flexible and pliable elongate ligature member having a first portion and a second portion that form a loop;
a housing comprising:
an opening configured to receive the first and second portions of the flexible and pliable elongate ligature member; and
a rod receiving member;
a rod locking mechanism configured to engage and fix a rod within the rod receiving member; and
a post-operative tension adjustment mechanism for adjusting the tension of the first and second portions of the flexible and pliable elongate ligature member in situ via winding the first and second portions.
2. The system of claim 1, wherein the post-operative tension adjustment mechanism includes a screw configured to be engaged with a driver.
3. The system of claim 2, wherein the post-operative tension adjustment mechanism includes a gear assembly disposed within the housing.
4. The system of claim 3, wherein the gear assembly includes a worm gear in threaded communication with threads of the screw, wherein the flexible and pliable elongate member is attached to the worm gear to enable the first and second portions to be wound around the worm gear.
5. The system of claim 1, wherein the rod locking mechanism includes a screw.
6. The system of claim 5, wherein the screw is configured to press against a rod positioned within the rod receiving member.
7. The system of claim 6, wherein the rod receiving member is a hook configured to hold a rod in a transverse relationship to the flexible and pliable elongate member offset from a winding axis for the first and second portions of the flexible and pliable elongate ligature member.
8. The system of claim 7, wherein the hook comprises an open hook configured to partially surround a circumference of the rod to permit the rod to be inserted and removed from the open hook in a direction transverse to a major axis of the rod.
9. The system of claim 1, wherein the rod locking mechanism includes a first screw and the post-operative tension adjustment mechanism includes a second screw, the first and second screws extending from a first side of the housing such that a user may access the first and second screws at substantially a single access point with respect to the housing.
10. The system of claim 1, wherein the post-operative tension adjustment mechanism includes a slot and the flexible and pliable elongate member is positionable through the slot, wherein the post-operative tension adjustment mechanism is rotatable in the housing to wrap the flexible and pliable elongate member around the post-operative tension adjustment mechanism.
11. The system of claim 10, wherein the slot extends through a receiving portion of the post-operative adjustment mechanism, the receiving portion being spaced laterally from a geared portion of the post-operative tension adjustment mechanism.
12. A system for post-operatively adjusting tension of a flexible elongated member, comprising:
a housing comprising:
an opening configured to receive the elongated member; and
a rod receiving member configured to receive a rod along a first axis;
a gear assembly disposed within the housing, the gear assembly including a worm gear including a slot through which the elongated member is configured to extend and a first screw in threaded communication with the worm gear, wherein the worm gear extends across the opening at the slot along a second axis and wherein the worm gear includes a geared portion and a receiving portion including the slot spaced laterally from the geared portion, wherein the geared portion is configured to threadingly engage the first screw and the elongated member is configured to be positioned to wrap around the receiving portion; and
a rod locking mechanism configured to engage and fix a rod within the rod receiving member;
wherein the first axis is offset from the second axis.
13. The system of claim 12, wherein the rod locking mechanism includes a second screw.
14. The system of claim 13, wherein the first and second screws extend from a first side of the housing such that a user may access the first and second screws at substantially a single access point with respect to the housing.
15. The system of claim 14, wherein the rod receiving member is disposed on a second side of the housing, opposite the first side.
16. The system of claim 13, wherein the first and second screws are substantially parallel and the worm gear is substantially perpendicular to the first and second screws.
17. The system of claim 12, wherein the receiving portion includes a slot configured to receive the elongated member such that the elongated member extends through the receiving portion in a direction transverse to an axis of a rod disposed in the rod receiving member.
18. The system of claim 12, wherein the elongated member is a pliant ligament.
19. The system of claim 12, wherein the rod receiving member is an open hook.
20. A system for post-operatively adjusting tension of a flexible elongated member, comprising:
a housing having a rod receiving member configured to receive a rod within the housing along an axis and an opening configured to receive the elongated member within the housing transverse to the axis, the rod receiving member comprising an open hook that is configured to partially surround a circumference of the rod to permit the rod to be inserted and removed from the open hook in a direction transverse to a major axis of the rod;
a gear assembly disposed within the housing, the gear assembly including a first screw extending through a first face of the housing, the gear assembly including an elongated member receiving member; and
a rod locking mechanism configured to engage and fix a rod within the rod receiving member, the rod locking mechanism including a second screw extending through the first face of the housing, wherein the rod receiving member is disposed on a second side of the housing, opposite the first side.
21. The system of claim 20, wherein the elongated member receiving member of the gear assembly includes a slot through which the elongated member can pass such that two portions of the elongated member can be simultaneously wound around the elongated member receiving member.
US14/794,329 2012-11-28 2015-07-08 Vertebral fixation system Active 2033-03-05 US10188429B2 (en)

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US14/794,329 US10188429B2 (en) 2012-11-28 2015-07-08 Vertebral fixation system

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